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United States Rvtent and Trademark Office 



UNITED STATES DEPARTMENT OF COMMERCE 

United State* Patent and Trademark Office 

Address: COMMISSIONER OF PATENTS AND TRADEMARKS 

Washington. D C. 20231 

www.uspto.gov 



APPLICATION NO. 



FILING DATE 



FjRST NAMED INVENTOR 



ATTORNEY DOCKET NO. 



CONFIRMATION NO. 



09/848,616 



05/04/2001 



Peter Sebbel 



1 700.0 180002/JAG/BJD 



6018 



26111 7590 08/30/2002 

STERNE, KESSLER, GOLDSTEIN & FOX PLLC 
1 100 NEW YORK AVENUE, N.W., SUITE 600 
WASHINGTON, DC 20005-3934 



EXAMINER 



MOSHER, MARY 



ART UNIT 



PAPER NUMBER 



1648 

DATE MAILED: 08/30/2002 



7 



Please find below and/or attached an Office communication concerning this application or proceeding. 



PTO-90C (Rev. 07-01) 



Office Action Summary 



Application No. 
09/848,616 



Applicants} 



Sebbel et al 



Examiner 



Mosher 



Art Unit 

1648 




~ The MAILING DATE of this communication appears on the cover sheet with the correspondence address - 
Period for Reply 

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE one MONTH(S) FROM 
THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may be available under the provisions of 37 CFR 1 .1 36 (a). In no event, however, may a reply be timery filed after SIX (6) MONTHS from the 
mailing date of this communication. 

- tf the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely- 

• If NO period for repty is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. 

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133). 

- Any reply received by the Office later than three months after the mailing date of this communication, even if timery filed, may reduce any 
earned patent term adjustment. See 37 CFR 1 .704(b). 

Status 

1)D Responsive to communication(s) filed on 

2a) □ This action is FINAL. 2b) This action is non-final. 

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is 

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11; 453 O.G. 213. 
Disposition of Claims 

4) K Claim(s) 1-85 



4a) Of the above, claim(s) 

5) D Claim(s) 

6) D Claim(s) 

7) D Claim(s) 

8) 8 Claims 1-85 



is/are pending in the application, 
is/are withdrawn from consideration. 

is/are allowed. 

is/are rejected. 

is/are objected to. 



are subject to restriction and/or election requirement. 



Application Papers 

9)D The specification is objected to by the Examiner. 

' 10)D The drawing(s) filed on is/are a) □ accepted or b)D objected to by the Examiner. 

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a). 

1 !)□ The proposed drawing correction filed on is: a)D approved b)D disapproved by the Examiner 

If approved, corrected drawings are required in reply to this Office action. 

12) D The oath or declaration is objected to by the Examiner. 
Priority under 35 U.S.C. §§ 119 and 120 

13) D Acknowledgement is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f). 
a)D All b)D Some* c)D None of: 

1 . □ Certified copies of the priority documents have been received. 

2. □ Certified copies of the priority documents have been received in Application No. 



3. □ Copies of the certified copies of the priority documents have been received in this National Stage 
application from the International Bureau (PCT Rule 17.2(a)). 
*See the attached detailed Office action for a list of the certified copies not received. 

14) D Acknowledgement is made of a claim for domestic priority under 35 U.S.C. § 1 19(e). 
a)D The translation of the foreign language provisional application has been received. 

15) D Acknowledgement is made of a claim for domestic priority under 35 U.S.C. §§120 and/or 121. 

Attachment(s) 

1 1 □ Notice of References Cited (PTO-892) 4) □ Interview Summary (PT0-41 3) Paper No(s). 

2) Q Notice of Dreftsperson's Patent Drawing Review (PT0-948) 5) □ Notice of Informal Patent Application (PT0-1 52) 

3) Q Information Disclosure Statemerrt(s) (PTO-1449) Paper No(s). 6) Q Other: 



U. S. Patent and Trademark Office 

PTO-326 (Rev. 04-01 ) 



Office Action Summary 



Part of Paper No. 7 



Application/Control Number: 98/848,616 
Art Unit: 1648 



Page 2 



DETAILED ACTION 

Applicant may wish to amend improper multiple dependent claims 48-56, 79, 80, 83-85; 
all of these claims depend from another multiple dependent claim. 

Election/Restriction 

This application contains claims directed to the following patentably distinct species of the 
claimed invention: 

1 . Pilus or pilin with covalently associated antigen 

2. Pilus or pilin with non-covalently associated antigen. 

3. Hepatitis B particle with covalently associated antigen. 

4. Hepatitis B particle with non-covalently associated antigen. 

Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for 
prosecution on the merits to which the claims shall be restricted if no generic claim is finally held 
to be allowable. Currently, no claim is generic. 

In addition, if a Hepatitis B particle is elected, applicant is directed to elect one species 
hepatitis B protein sequence from those listed in claim 34 or 28. Since alteration of amino acids 
can have unpredictable effects upon the function of a polypeptide, each sequence is seen as 
potentially patentably distinct. 

Applicant is advised that a reply to this requirement must include an identification of the 
species that is elected consonant with this requirement, and a listing of all claims readable thereon, 



Application/Control Number: 98/848,616 
Art Unit: 1648 



Page 3 



including any claims subsequently added. An argument that a claim is allowable or that all claims 
are generic is considered nonresponsive unless accompanied by an election. 

Upon the allowance of a generic claim, applicant will be entitled to consideration of claims 
to additional species which are written in dependent form or otherwise include all the limitations 
of an allowed generic claim as provided by 37 CFR 1.141. If claims are added after the election, 
applicant must indicate which are readable upon the elected species. MPEP § 809.02(a). 

Should applicant traverse on the ground that the species are not patentably distinct, 
applicant should submit evidence or identify such evidence now of record showing the species to 
be obvious variants or clearly admit on the record that this is the case. In either instance, if the 
examiner finds one of the inventions unpatentable over the prior art, the evidence or admission 
may be used in a rejection under 35 U.S. C. 103(a) of the other invention. 

Applicant is reminded that upon the cancellation of claims to a non-elected invention, the 
inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently 
named inventors is no longer an inventor of at least one claim remaining in the application. Any 
amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the 
fee required under 37 CFR 1.17(i). 

Any inquiry concerning this communication or earlier communications from the examiner 
should be directed to Mary E. Mosher, Ph.D. whose telephone number is (703) 308-2926. The 
examiner can normally be reached on Monday -Thursday and alternate Fridays from 6:30 AM to 
4:00 PM. 



Application/Control Number: 98/848,616 
Art Unit: 1648 



Page 4 



If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, 
James Housel, can be reached on (703) 308-4027. The fax phone number for this Group is now 
(703) 308-4242. 

Any inquiry of a general nature or relating to the status of this application or proceeding 
should be directed to the Group receptionist whose telephone number is (703) 308-0196. 

August 29, 2002 




MARYE.MOSHER 
PRIMARY EXAMINER 
GROUP MM"